In litigation, claims are subject to statutes of limitations. Because the passage of time can affect such things as witness memory and evidence preservation, states pass statutes of limitations providing that claims cannot be brought after the expiration of a certain number of years after a claim arises. While the statutes of limitations vary from state to state and from claim to claim, limitation periods of one, two, or three years are common. Although there are special rules that may delay or otherwise alter the date on which a limitations period begins, once the period expires, a claim cannot be brought.

This is not the case with research misconduct allegations involving Public Health Service funds. These allegations are subject to a limitations period, but the period is applied differently than a statute of limitations in litigation. The Public Health Service regulations (42 C.F.R.§ 93.105(a))¹ provide as follows:

(a) Six-year limitation. This part applies only to research misconduct occurring within six years of the date HHS or an institution receives an allegation of research misconduct.

At six years, the research misconduct period of limitations is longer than many state statutes of limitations. Moreover, the six-year limitation provision is subject to a “subsequent use exception” which applies if “[t]he respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the citation, republication or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized.” 42 C.F.R.§ 93.105(b)(1).

The trigger event for the limitations period is the date the research misconduct – the alleged falsification, fabrication or plagiarism – occurs. However, because of the subsequent use exception in Section (b), the research misconduct remains subject to investigation, even after the expiration of the six years, if it is cited, republished, or otherwise used for the respondent’s benefit. Each such occurrence starts the running of the six year period anew.

Thus, a figure that is falsified could be subject to a misconduct investigation well past the six year mark if it is cited in a later publication. Consider this scenario: In 2002, Scientist A conducts a series of experiments. In 2004, he creates figures based on the experiment data for Manuscript No. 1. Finally, in 2007, Manuscript No.1, containing the figures, is published. In 2010, Scientist A cites to the figures in Manuscript No. 1 in Manuscript No. 2. Six years later, in 2016, Complainant alleges that Scientist A falsified the figures. The allegations are timely, even though the figure was falsified in 2004, twelve years before the allegation was made and the experiment resulting in the figures took place fourteen years before the allegation was made.

Although called a “limitation” period, the period is not as strictly applied in research misconduct proceedings as are limitations periods in litigation. In litigation, limitations periods are strictly applied to bar claims, including those that may well be meritorious. If the complaint is filed even a day too late, a motion to dismiss it will likely be granted absent some extraordinary circumstance. In research misconduct cases, however, institutions do not strictly impose the time limit. They often interpret “six years” to mean “approximately” six years. This seems particularly true where, although a timely allegation may be brought to commence the inquiry, additional questions arise during the course of the investigation regarding older unrelated publications and new allegations are brought. It is not uncommon to have alleged misconduct investigated even though the misconduct occurred six years plus a couple months, or even plus a couple of years, earlier – even where the institution has not established that the subsequent use exception applies.

The loose application of the limitations period in science misconduct cases is an unfortunate reality for scientists. It is difficult for a scientist to remember the details of one or two experiments which occurred seven, eight, nine or even more years prior to allegations being made. This is especially true for scientists in a busy lab, with many experiments and many publications. The scientist may seem insincere to committee members in saying “I don’t remember” time after time during an interview, even though the comment is completely true. Additionally, a scientist’s inability to locate data many years later frequently causes investigative committees to become suspicious. Requiring institutions to adhere to a strict six year time limit and to limiting the subsequent use exception would bring a measure of predictability and fairness that is supposed to be afforded a respondent in a misconduct proceedings by virtue of 42 C.F.R. Section 93.105.

¹ There are two additional exceptions. The first is where the public’s health or safety would be substantially adversely effected if the alleged misconduct did occur. 42 C.F.R. §93.105(b)(2). The second is a grandfather clause providing that the time limitations in Section 93.105(a) do not apply “[i]f HHS or an institution received the allegation of research misconduct before the effective date” of the regulations. 42 C.F.R. §93.105(b)(3). The effective date is June 16, 2005. It is probably unlikely that allegations received prior to June 16, 2005 are still being investigated.